Effect of Lutemax 2020 on blue light and visual health markers

ISRCTN	ISRCTN16156382
DOI	https://doi.org/10.1186/ISRCTN16156382
Secondary identifying numbers	BL Study I and II/

Submission date: 23/03/2016
Registration date: 22/04/2016
Last edited: 21/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
In the retina (the layer at the back of the eye which is sensitive to light), there is a yellow pigment called macular pigment. This pigment is made up of three carotenoids (lutein, zeaxanthin and meso-zeaxanthin). These carotenoids are obtained from the diet and are thought to be important for preserving and improving vision. This study is going to look at the relationship between macular carotinoids and visual function in order to find out if taking a supplement called Lutemax 2020 (which contains lutein and zeaxanthin) can help to improve contrast sensitivity, visual processing and glare sensitivity.

Who can participate?
Adults aged between 18 and 25 who are exposed daily to high energy sources such as UV, blue light and electronic devices such as TV, computer , IPAD and cell phones for at least more than four hours per day.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group take a capsule of Lutemax 2020, which contains 20 mg Lutein and 4 mg Zeaxanthin, once a day for six months. Participants in the second group take a capsule containing safflower oil, which acts as a placebo (dummy), once a day for six months. Participants in both groups undergo a number of visual tests as well as providing a blood sample so that lutein levels can be measured. In addition, participants also complete a number of questionnaires in order to measure their general health cognitive function (thinking, processing and memory).

What are the possible benefits and risks of participating?
Participants may benefit from learning more about their own visual function and the role that macular carotinoids play. There are no significant risks involved but some participants may experience pain, bleeding or bruising following blood sample collection.

Where is the study run from?
University of Georgia (USA)

When is the study starting and how long is it expected to run for?
May 2015 to February 2016

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Nafisah B Atako
mrcctu.stophcv1@ucl.ac.uk

Contact information

Dr Vijaya Juturu
Scientific

OmniActive Health Technologies Inc.
67 East Park Place
Suite 500
Morristown
07960
United States of America

ORCID ID	0000-0002-7397-715X

Study information

Study design	Double-blind randomized placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Macular carotenoids and blue light: Relationships with visual performance, sleep, health, and quality of life
Study hypothesis	The aim of this study is to evaluate the effects of macular carotenoids on visual function tests and sleep improvement over placebo.
Ethics approval(s)	The University of Georgia Office of the Vice President for Research Institutional Review Board, 19/06/2015, ref: 00001914
Condition	Eye damage
Intervention	Participants are randomly allocated to one of two study groups. Intervention group: Participants take a capsule of Lutemax 2020, which contains 20 mg Lutein and 4 mg Zeaxanthin isomers, once a day for six months. Control group: Participants take a capsule containing a placebo (safflower oil) once a day for six months. Participants attend study visits at baseline, 3 and 6 months.
Intervention type	Supplement
Primary outcome measure	1. Contrast sensitivity is determined using a computer-based, 2-alternative, forced-choice procedure at baseline, 3 and 6 months 2. Glare sensitivity is measured using the disability glare performance task and the photostress recovery performance task at baseline, 3 and 6 months 3. Macular pigment optical density is assessed via heterochromatic flicker photometry at baseline, 3 and 6 months
Secondary outcome measures	1. Psychological stress is measured using the Psychological Stress Measure (PSM-9) and the Brief Symptom Inventory (BSI) at baseline, 3 and 6 months 2. Lutein concentration is measured by High-Performance Liquid Chromatography (HPLC) and Enzyme-linked Immune Sorbent Assay (ELISA) using blood samples at baseline, 3 and 6 months 3. General health status is measured at baseline, 3 and 6 months using the following: 25-item Suboptimal Health Status Questionnaire (SHSQ-25). 3.1. SCL 90-r overall affect assessment 3.2. Beck Depression Inventory 3.3. Beck Anxiety Inventory 3.4. Dietary Questionnaire 3.5. A standard cognitive battery (RBANS-update) 3.6. The Pittsburgh Sleep Quality Index (PSQI) 3.7. A questionnaire on different attributes including frequencies such as head ache, eye strain and eye fatigues will be questioned before and after supplementation
Overall study start date	02/05/2015
Overall study end date	03/02/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	N=45
Participant inclusion criteria	1. Two-three hours of outside activity per day will be recruited with preference, due to blue light exposure 2. MPOD of subjects ≤0.69 3. One or more of the following symptoms: 3.1. Accommodative issues (difficulty seeing in the distance after prolonged nearwork) 3.2. Digital eyestrain 3.3. Blurry vision 3.4. Difficulty focusing 3.5. Dry and irritated eyes 3.6. Headaches 3.7. Neck and/or back pain 4. Aged 18 to 25 years
Participant exclusion criteria	1. Body Mass Index of 30 or greater 2. Macular pigment optical density (MPOD) of 0.70 or higher 3. Ocular disease or insufficient visual acuity (cut off 20/30 visual acuity) 4. Systemic disease or any chronic disease condition 5. Smokers 6. Current use of psychiatric medication
Recruitment start date	16/05/2015
Recruitment end date	18/06/2015

Locations

Countries of recruitment

United States of America

Study participating centre

University of Georgia

UGA Psychology Department
125 Baldwin Street
Athens
Athens
30602
United States of America

Sponsor information

OmniActive Health Technologies Inc.
Industry

67 East Park Place
Suite 500
Morristown
07960
United States of America

Website	http://www.omniactives.com
"ROR"	https://ror.org/024e1pj18

Funders

Funder type

Industry

OmniActive Health Technologies
Private sector organisation / For-profit companies (industry)

Location: United States of America

Results and Publications

Intention to publish date	12/12/2016
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer reviewed journal.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/06/2017		Yes	No
Results article	results	19/06/2018		Yes	No
Results article	results	01/11/2019	21/08/2019	Yes	No

Editorial Notes

21/08/2019: Publication reference added.
31/07/2018: Publication references added.